“Reducing the Risks from Smoking—A New U.S. Regulatory Framework”

It was very informative. Breakout session No. 5 at the Global Tobacco & Nicotine Forum (GTNF) focused on reducing the risks from smoking in an ever-changing U.S. regulatory environment. The panelists included representatives from the manufacturing and distribution segments, as well as scientific research officials from the China National Tobacco Quality and Supervision Center.

Moderator Brittani Cushman, vice president of external affairs at Turning Point Brands, began the session by discussing the U.S. Food and Drug Administration’s (FDA) new nicotine policy. The regulatory agency is making a strong push toward lowering nicotine levels in cigarettes to “minimally or nonaddictive levels,” according to FDA Commissioner Scott Gottlieb.

The current proposal is not beneficial to public health, which is supposed be a main goal for the FDA, according to one panelist. She said that if the FDA decides to keep cigarettes on the market, even just with lower nicotine, they are reinforcing the misconception that nicotine is the problem. “The true problem is combustion,” she said.

Another panelist explained that an additional issue for low-nicotine cigarettes is that they would disrupt the supply chain. “Farmers around the world, more so in U.S., would have to grow different types of tobacco, for example,” she said. “It would also require the possibility of using genetically modified (GMO) tobacco. There would be shortages of lowered-nicotine tobacco, disrupting the entire supply chain.”

She also stated that if farms had to use GMO tobacco, that tobacco would require its own supply chain to prevent cross-contamination. “New GMO tobaccos would have to be processed in separate facilities, transported in separate trucks and manufactured in separate factories,” she said. “Low-nicotine tobacco would also possibly increase the need for pesticides since nicotine serves as a natural pesticide, which would be more damaging to the environment.”

Additionally, Chinese studies have showed that lower-nicotine cigarettes cause consumers to smoke more cigarettes to get the nicotine they need. This would go directly against the FDA’s goal of bettering public health.

One lower-risk product mentioned was snus. The FDA needs to approve snus as a modified-risk tobacco product (MRTP) to show that the pathway is possible, according to a panelist. Snus, which first became popular in Sweden, is sold in teabag-like pouches of loose tobacco that users stick between their cheeks and gums but that doesn’t require spitting.

During the same time as the GTNF, the Tobacco Products Scientific Advisory Committee (TPSAC), which advises the FDA, met to discuss six MRTP applications submitted by R.J. Reynolds Tobacco Co. (RJR) for six varieties of its Camel Snus products. TPSAC approved advancing the applications for Camel Snus to the agency. RJR submitted its applications in April 2017. The submissions totaled more than 450,000 pages of data and scientific research.

Panelists agreed that the science is still emerging in lowered-risk tobacco products. “We know a lot about smokeless [tobacco] and there is progress there, but we know very little about the vapor industry,” said one panelist, adding that considering the agency’s current battle against flavors in tobacco products, maybe the lower-nicotine route is no longer a focus. Vapor may potentially be a stronger focus for the agency moving forward.

Innovation in the vapor industry is not possible because the FDA froze the market in August of 2016. One panelist reflected that this means that the products consumers are using in the U.S. have technology that is two years old. “This industry is constantly updating its technology, and those innovations, especially ones that deal with safety, should be allowed,” she said.

That could be accomplished if the FDA could find a way to offer some sort of enforcement discretion when dealing with certain innovations, another panelist suggested. “The FDA needs to step up and express the relatively lower risks offered by these products,” they said.

The FDA has said the agency would release clearer guidelines concerning the premarket tobacco product application (PMTA) and MRTP pathways to bring these lower-risk products to market, but that hasn’t happened yet. The panelists agreed that the agency needs to let consumers know that there are lower-risk options available than smoking combustible, even if they are lower-nicotine, cigarettes.

“Even just an acknowledgment that while no product is completely safe, some of these products are safer,” she said. “We understand that it will take time. However, the FDA needs to help change the focus or we will be stuck in this stalemate for a long time.”